Traumatic Brain InjuryPhase 2NCT00221689
Intrathecal Baclofen Therapy and Paroxysmal Dysautonomia in Severe Brain-Injured Patients
A Phase 2 study testing baclofen (drug) in people with Traumatic Brain Injury and Cerebral Anoxia, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
Within the framework of a prospective double-blind and randomized study evaluating the efficacy of continuous intrathecal baclofen therapy (CIBT) on paroxysmal dysautonomia (main objective) and hypertonia, recovery and tolerance (secondary objectives) during the initial recovery phase of severe head injury, continuous… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Traumatic Brain Injury, Cerebral Anoxia, Coma
- What is being tested?
- baclofen (drug)
- How many people
- 4 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2003to Feb 2004
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- severe brain injury with coma (Glasgow score <8)
- Early phase of recovery (spontaneous eye-opening) since at least one month and less than six months
- severe hypertonia of the lower limbs (mean Ashworth score >= 3) with neurovegetative episodes (at least 10 in 48 hours) and/or decortication after failure of treatment per os (clonidine, beta-blocker, baclofen per os)
- written informed consent (next of kin)
Who cannot join
- surgical, anesthetic or allergic contraindication to baclofen
- uncontrolled sepsis directly threatening the implanted device
- associated medullary trauma
Trial locations and contacts
1 site in 1 country.
France1 site
Service de neurochirurgie B, Hôpital Pellergin Tripode
Bordeaux, 33076
About this study
Official title: Early Treatment of Paroxysmal Dysautonomia and Hypertonia for Severe Brain Injured Patients by Intrathecal Baclofen Therapy
Within the framework of a prospective double-blind and randomized study evaluating the efficacy of continuous intrathecal baclofen therapy (CIBT) on paroxysmal dysautonomia (main objective) and hypertonia, recovery and tolerance (secondary objectives) during the initial recovery phase of severe head injury, continuous intrathecal baclofen infusion will be delivered. The first week of study is double-blind: the first of two parallel groups receives CIBT and the second group receives placebo. The main outcome (number of neurovegetative episodes) is assessed at the end of first week. The second week of study is open labeled: active treatment is continued in the first group and the second group starts active CIBT treatment. The third week of study, treatment is stopped in both groups.
Read the detailed description
Background. Severe brain trauma and especially serious brain lesions inducing coma lead to many cases of disability. A large number of these patients (about 30%) present neurovegetative and hypertonic episodes that are associated to a bad vital prognosis and the degree of disability. Several teams including two in France have reported the efficacy of intrathecal baclofen on such neurovegetative episodes that to date have not been able to be treated efficiently.
Objectives. The main objective of this trial is to assess the efficacy of infused intrathecal baclofen on the number of neurovegetative episodes in seriously brain-injured patients. The secondary aims are to evaluate the efficacy of the treatment on hypertonia, to assess changes in waking and treatment safety.
Study design. Double-blind randomized trial on two parallel groups. The second part of the study is open label: both groups receive the experimental treatment.
Intervention
Experimental group: continuous progressive dose of intrathecal baclofen for one week; constant dose of baclofen during the second week receives at a dose determined after the first week. Treatment is stopped after two weeks, but patients are assessed until the end of the third week.
Control group: intrathecal placebo for one week; progressive dose of intrathecal baclofen during the second week. Treatment is stopped after two weeks, but patients are assessed until the end of the third week.
Outcomes. The main outcome is the number of neurovegetative episodes in the last 48 hours of the first week of treatment. Secondary outcomes are hypertonia as measured by the Ashworth scale on D2 to D5 of all three weeks. Waking will be assessed by the WHIM scale on D5 each week. Adverse events are assessed throughout the 3 weeks of study.
Eligibility criteria. Inclusion criteria are focal or diffuse encephalic lesions leading to coma (Glasgow score <8), age 18 years or over, in waking phase (spontaneous eye-opening) since at least one month and less than six months, severe hypertonia of the lower members (mean Ashworth score >= 3) with neurovegetative episodes (at least 10 in 48 hours) and/or decortication after failure of treatment per os (clonidine, beta-blocker, baclofen per os). Non inclusion criteria are surgical, anesthetic or allergic contraindication to baclofen, uncontrolled sepsis directly threatening the implanted device or associated medullary trauma.
Expected results. Throughout the trial the patients will be hospitalized in the neurosurgical or neurological intensive care departments. Expected results are a very clear decrease in the number of neurovegetative episodes and a substantial reduction in hypertonia, at least in the lower limbs. It will also be possible to quantify the consequences of these improvements on waking.
- Conditions
- Traumatic Brain Injury, Cerebral Anoxia, Coma, Hypertonia, Dysautonomia
- Being tested
- baclofen (drug)
- Keywords
- Severe brain injury, Coma, Hypertonia, Dysautonomia, Baclofen, Randomized Controlled Trials
- Medical subject headings
- Brain Injuries, Traumatic, Hypoxia, Brain, Coma, Muscle Hypertonia, Autonomic Nervous System Diseases, Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
baclofen (drug)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of neurovegetative episodes
Measured: day 6 and day 7
Secondary outcomes (3)
Ashworth scale
Whim scale
Adverse events
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startMar 2003
- Study completionFeb 2004
Why it stopped: very slow recruitment and treatments beyond expiry date
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Investigators
- Emmanuel Cuny, Professor, Principal investigator, University Hospital, BordeauxPaul Perez, Dr, Study chair, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00221689
- Sponsor's protocol ID
- 9244-01
- Other IDs
- 2001-009
- Status last verified
- Jun 2007
- First submitted
- 13 Sep 2005
- Last updated
- 13 Jun 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Treatment of Paroxysmal Dysautonomia and Hypertonia for Severe Brain Injured Patients by Intrathecal Baclofen Therapy
- ClinicalTrials.gov ID
- NCT00221689
- Acronym / sponsor ID
- 9244-01
- Conditions
- Traumatic Brain Injury, Cerebral Anoxia, Coma, Hypertonia, Dysautonomia
- Keywords
- Severe brain injury, Coma, Hypertonia, Dysautonomia, Baclofen, Randomized Controlled Trials
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: very slow recruitment and treatments beyond expiry date
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- Mar 2003
- Study completion
- Feb 2004 (actual)
- First posted
- 22 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Within the framework of a prospective double-blind and randomized study evaluating the efficacy of continuous intrathecal baclofen therapy (CIBT) on paroxysmal dysautonomia (main objective) and hypertonia, recovery and tolerance (secondary objectives) during the initial recovery phase of severe head injury, continuous intrathecal baclofen infusion will be delivered. The first week of study is double-blind: the first of two parallel groups receives CIBT and the second group receives placebo. The main outcome (number of neurovegetative episodes) is assessed at the end of first week. The second week of study is open labeled: active treatment is continued in the first group and the second group starts active CIBT treatment. The third week of study, treatment is stopped in both groups.
Detailed description
Background. Severe brain trauma and especially serious brain lesions inducing coma lead to many cases of disability. A large number of these patients (about 30%) present neurovegetative and hypertonic episodes that are associated to a bad vital prognosis and the degree of disability. Several teams including two in France have reported the efficacy of intrathecal baclofen on such neurovegetative episodes that to date have not been able to be treated efficiently.
Objectives. The main objective of this trial is to assess the efficacy of infused intrathecal baclofen on the number of neurovegetative episodes in seriously brain-injured patients. The secondary aims are to evaluate the efficacy of the treatment on hypertonia, to assess changes in waking and treatment safety.
Study design. Double-blind randomized trial on two parallel groups. The second part of the study is open label: both groups receive the experimental treatment.
Intervention
Experimental group: continuous progressive dose of intrathecal baclofen for one week; constant dose of baclofen during the second week receives at a dose determined after the first week. Treatment is stopped after two weeks, but patients are assessed until the end of the third week.
Control group: intrathecal placebo for one week; progressive dose of intrathecal baclofen during the second week. Treatment is stopped after two weeks, but patients are assessed until the end of the third week.
Outcomes. The main outcome is the number of neurovegetative episodes in the last 48 hours of the first week of treatment. Secondary outcomes are hypertonia as measured by the Ashworth scale on D2 to D5 of all three weeks. Waking will be assessed by the WHIM scale on D5 each week. Adverse events are assessed throughout the 3 weeks of study.
Eligibility criteria. Inclusion criteria are focal or diffuse encephalic lesions leading to coma (Glasgow score <8), age 18 years or over, in waking phase (spontaneous eye-opening) since at least one month and less than six months, severe hypertonia of the lower members (mean Ashworth score >= 3) with neurovegetative episodes (at least 10 in 48 hours) and/or decortication after failure of treatment per os (clonidine, beta-blocker, baclofen per os). Non inclusion criteria are surgical, anesthetic or allergic contraindication to baclofen, uncontrolled sepsis directly threatening the implanted device or associated medullary trauma.
Expected results. Throughout the trial the patients will be hospitalized in the neurosurgical or neurological intensive care departments. Expected results are a very clear decrease in the number of neurovegetative episodes and a substantial reduction in hypertonia, at least in the lower limbs. It will also be possible to quantify the consequences of these improvements on waking.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- severe brain injury with coma (Glasgow score <8)
- Early phase of recovery (spontaneous eye-opening) since at least one month and less than six months
- severe hypertonia of the lower limbs (mean Ashworth score >= 3) with neurovegetative episodes (at least 10 in 48 hours) and/or decortication after failure of treatment per os (clonidine, beta-blocker, baclofen per os)
- written informed consent (next of kin)
Key exclusion criteria (3 listed)
- surgical, anesthetic or allergic contraindication to baclofen
- uncontrolled sepsis directly threatening the implanted device
- associated medullary trauma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| baclofen (drug) | Drug | – |
Primary outcome
Number of neurovegetative episodes
Time frame: day 6 and day 7
3 secondary outcomes
Ashworth scale
Whim scale
Adverse events
Results and safety
The study was stopped early (reason given: very slow recruitment and treatments beyond expiry date). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emmanuel Cuny, Professor principal investigator
University Hospital, Bordeaux
Paul Perez, Dr study chair
University Hospital, Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing baclofen (drug) in people with Traumatic Brain Injury and Cerebral Anoxia, run by University Hospital, Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Jun 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: very slow recruitment and treatments beyond expiry date). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of neurovegetative episodes (time frame: day 6 and day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2007.